[Federal Register Volume 64, Number 68 (Friday, April 9, 1999)]
[Notices]
[Pages 17397-17399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0391]


International Standard-Setting Activities; Codex Alimentarius 
Commission; Committee on Nutrition and Foods for Special Dietary Uses; 
Background Paper to Identify Perspectives and Issues Pertaining to 
International Guidelines on Vitamin and Mineral Supplements

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is asking interested 
persons to submit comments that will be used by the U.S. delegate to 
the Codex Committee on Nutrition and Foods for Special Dietary Uses 
(CCNFSDU) to prepare a background paper to be considered by the CCNFSDU 
prior to its considering the appropriateness of establishing guidelines 
for vitamin and mineral supplements for the purposes of international 
trade. The background paper will discuss the range of concerns and the 
differences in rationales on this topic. The United States, which has 
indicated its opposition to the development of such guidelines, has 
been asked to participate in the development of this background paper 
along with other governments. FDA is accepting this request in its role 
as the agency representing the United States in the CCNFSDU.
DATES:  Submit written comments by June 8, 1999.
ADDRESSES: Submit written comments and recommendations to the Dockets 
Management Branch (HFA-305), Food

[[Page 17398]]

and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food 
Safety and Applied Nutrition (HFS-456), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4605.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The Codex Alimentarius Commission (Codex) is the joint food 
standards program of the Food and Agriculture Organization of the 
United Nations (FAO) and the World Health Organization (WHO). This 
program was established in 1962 and develops food standards, codes of 
practice, and other guidelines to help protect the health and economic 
interests of consumers and to facilitate and encourage fair 
international trade in food. The Codex accomplishes these actions 
through the use of subordinate committees that develop food standards, 
codes of practice, and other guidelines for consideration and adoption 
by the Codex and member countries.
    In the United States, the U.S. Department of Agriculture (USDA), 
FDA, and other agencies manage and carry out U.S. Codex activities. 
Executive direction of this effort comes from the U.S. manager for 
Codex, a responsibility of the Food Safety and Inspection Service 
(FSIS) of USDA. For more information on U.S. Codex activities and the 
responsibilities of the U.S. delegates to Codex committees, see the 
Federal Registers of May 27, 1998 (63 FR 28966), and February 12, 1998 
(63 FR 7118), respectively. Under section 491 of the Trade Agreements 
Act of 1979 (19 U.S.C. 2578), as amended, and the Uruguay Round 
Agreements Act, Pub. L. 103-465, 108 Stat. 4809, FSIS must inform the 
public of the sanitary and phytosanitary standard setting activities of 
international standard-setting organizations, such as Codex. The most 
recent annual notice was published in the May 27, 1998, Federal 
Register. That notice identified FDA as the responsible agency for the 
United States with respect to the activities of the CCNFSDU (63 FR 
28966 at 28973). Accordingly, the U.S. delegate to the CCNFSDU is from 
FDA.
    This notice solicits information and comments relative to the 
content of a background document that is intended to identify the 
nature of and basis for differences in perspectives on establishing 
guidelines for vitamin and mineral supplements in international trade. 
This document is a component of the sanitary and phytosanitary 
standard-setting activities of the CCNFSDU with regard to its 
consideration of guidelines for vitamin and mineral supplements (Ref. 
1).

II. Background

    Germany proposed a process to consider the development of 
guidelines for vitamin and mineral supplements at the October 1995 
meeting of the CCNFSDU. Germany submitted the draft proposed guidelines 
(Ref. 2), which were intended to address such issues as the composition 
and labeling of vitamin and mineral supplements, including lists of 
allowable vitamins and minerals and their sources, minimum and maximum 
levels, permissible additives, packaging, labeling requirements, and 
permissible claims. Codex circulated the proposal to member governments 
for comment, and it was considered at the October 7 to 11, 1996, 
CCNFSDU committee meeting (Ref. 3).
    At that meeting, the United States, through its delegate, indicated 
its opposition to the development of the guidelines. Such guidelines 
would not affect dietary supplements within the United States, whose 
sale and marketing is regulated under the Federal Food, Drug, and 
Cosmetic Act, as amended by the Dietary Supplement Health and Education 
Act of 1994. However, such guidelines, were they developed and adopted 
by other countries, could affect international trade in vitamin and 
mineral supplements. In particular, such guidelines could have 
ramifications for those U.S. manufacturers of dietary supplements that 
export their products to countries that adopt such guidelines.
    CCNFSDU did not reach consensus on many aspects of the draft 
proposed guidelines, but nonetheless, they forwarded the draft proposed 
guidelines to Codex and recommended that the draft proposed guidelines 
be advanced to the next level of consideration. Codex considered the 
recommendation of the committee at its June 23 to 28, 1998, meeting in 
Rome, Italy (Ref. 4). The United States, through its delegate, again 
indicated its opposition to the advancement of the guidelines during 
the Codex meeting.
    Codex did not advance the draft proposed guidelines to the next 
level of consideration, but instead Codex returned them to the CCNFSDU 
for further discussion and consideration. Codex also advised the 
CCNFSDU to reconsider whether there was a need to proceed with the 
development of the guidelines.
    The CCNFSDU considered the draft proposed guidelines again at its 
September 21 to 25, 1998, meeting (Ref. 1). A copy of this document may 
be downloaded from the internet at ``www.fao.org/es%2A/esn/codex/
reports.htm''. The CCNFSDU discussed the draft proposed guidelines and 
decided that while it was premature to stop work on the draft proposed 
guidelines, there was not enough agreement to advance the proposed 
draft guidelines for vitamin and mineral supplements to the next level 
of consideration. Consequently, the draft proposed guidelines remained 
at their current level of consideration. Because there was no consensus 
on the need for the proposed guidelines or what they should contain, 
the CCNFSDU decided that it would be useful to reconsider the basis for 
continuing work on the draft proposed guidelines. The CCNFSDU believed 
that it would facilitate its work if it could prepare a background 
paper that would: (1) Provide ``a neutral and objective presentation on 
the issues that should be considered on this subject'', (2) ``help 
understand the rationale behind the different approaches'', and (3) 
``be useful to study in depth the principles justifying each particular 
position in order to find a common ground for discussion'' (Ref. 1).
    The CCNFSDU chair asked the U.S. Government to contribute to this 
background paper, which will be considered at the next meeting of the 
CCNFSDU in the year 2000. The U.S. delegate agreed to this request. The 
U.S. delegate concluded that there is value in assisting with the 
development of an objective background paper that addresses the various 
perspectives, approaches, and difficulties associated with developing 
guidelines for international trade in vitamin and mineral supplements. 
This activity is consistent with the U.S. interests in this matter and 
will facilitate the decisionmaking process of the CCNFSDU.

III. Request for Comments

    Interested persons may, on or before June 8, 1999, submit to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.
    Based on the interest of the CCNFSDU in identifying the pros and 
cons of developing guidelines for vitamin and mineral supplements and 
in identifying

[[Page 17399]]

the various factors and principles pertaining to international 
guidelines for vitamin and mineral supplements, FDA is asking for 
comments that identify the range of perspectives associated with the 
manufacture, use, and regulation of such products, as well as the 
specific issues that the paper should address. Moreover, the CCNFSDU 
intends to develop a paper that considers only issues relevant to 
vitamin and mineral supplements. The CCNFSDU does not intend that the 
paper will consider the addition of vitamins and minerals to 
conventional foods nor products containing other ingredients or 
substances, for example herbs or other botanicals. Accordingly, 
comments on such matters will not assist the U.S. delegate to 
contribute to the CCNFSDU paper.
    For the purposes of international trade, FDA has identified topics 
that should be addressed in the background paper. The topics identified 
for comment are as follows: (1) Topic 1 focuses on terminology, such as 
the use of the terms ``food supplements'' or ``dietary supplements,'' 
as compared to ``vitamin and mineral supplements;'' (2) topic 2 focuses 
on the purpose and role of vitamin and mineral supplements; (3) topic 3 
focuses on the concept of ``approved nutrients'' (i.e., a positive or 
negative list of nutrients for use in the supplements of issue); (4) 
topic 4 focuses on setting maximum levels for vitamins and minerals in 
supplement form; (5) topic 5 focuses on setting minimal limits for 
vitamins and minerals in such products; (6) topic 6 focuses on purity 
and good manufacturing practices; (7) topic 7 focuses on labeling, 
warning statements, and claims; and (8) topic 8 focuses on packaging 
and marketing.
    For each topic, specific comments would be most helpful if they 
addressed the following: (1) Is there a need for the topic? (2) What 
are the various perspectives on the topic and what the difficulties in 
addressing these perspectives? and (3) What are the options for making 
decisions about the topic?
     We also welcome comments on the inclusion of additional topics. It 
would be most helpful if the additional topic(s) could be addressed in 
a fashion so as to respond to the three basic questions identified for 
the other topics listed previously.

IV. References

     The following references have been placed on display in the 
Dockets Management Branch (address above) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Codex Alimentarius Commission, ``Report of the Twenty-First 
Session of the Codex Committee on Nutrition and Foods for Special 
Dietary Uses,'' ALINORM 99/26, FAO/WHO, Rome, 1998.
    2. Codex Alimentarius Commission, ``Report of the Twentieth 
Session of the Codex Committee on Nutrition and Foods for Special 
Dietary Uses,'' ALINORM 97/26, FAO/WHO, Rome, 1996.
    3. Codex Alimentarius Commission, ``Report of the Nineteenth 
Session of the Codex Committee on Nutrition and Foods for Special 
Dietary Uses,'' ALINORM 95/26, FAO/WHO, Rome, 1995.
    4. Codex Alimentarius Commission, ``Report of the Twenty-Second 
Session of the Codex Alimentarius Commission,'' ALINORM 97/4, FAO/
WHO, Rome, 1997.

    Dated: April 2, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8796 Filed 4-8-99; 8:45 am]
BILLING CODE 4160-01-F